Esophyx ve Endoskopik Reflü Tedavisi İle İlgili Makale Özetleri
1: Surg Innov. 2008 Sep;15(3):166-70. Endolumenal fundoplication with EsophyX: the initial North American experience.Bergman S, Mikami DJ, Hazey JW, Roland JC, Dettorre R, Melvin WS.
Department of Surgery, Center for Minimally Invasive Surgery, The Ohio State University, Columbus, Ohio 43210, USA.
EsophyX is a novel endolumenal therapeutic option for the treatment of gastroesophageal reflux disease (GERD). The device is passed into the stomach, where it deploys a series of full-thickness fasteners to create a neogastroesophageal valve. The objective of this study was to demonstrate the safety and characterize the effectiveness of this approach in the initial North American experience. This is a retrospective study of consecutive patients with GERD who had undergone endolumenal fundoplication with the EsophyX device. At follow-up, proton pump inhibitor usage was elicited and 2 validated questionnaires were administered measuring GERD health-related quality of life (range 0-50) and symptom severity (range 0-72). In limited preliminary evaluation, the initial North American experience with endolumenal fundoplication using the EsophyX device is that it appears to be safe and provides moderate effectiveness in treating the symptoms of GERD. Further studies comparing this technique with conventional medical and surgical therapies are necessary.
2: J Clin Gastroenterol. 2007 Jul;41 Suppl 2:S87-96 Endotherapy and surgery for GERD.Triadafilopoulos G.
Today, there are several modalities to treat gastroesophageal reflux disease (GERD) (medications, endoscopic therapies, surgery) and such therapies can be used either singly, or in tandem, or in combination with the others, aiming at “normalization” of the patient’s GERD-related quality of life and, if possible, esophageal acid exposure. Several intermediate end points or clinically significant outcomes have not been reached by some therapeutic modalities and no single modality is or can be perfect. Statistically significant improvements in these intermediate end points have been shown in “some” but not all studies. Although healing of esophagitis can be accomplished with either medical or surgical therapy, there is inadequate data with endotherapies, because most patients treated with endotherapies have had prior trials of proton pump inhibitors (PPIs) and hence healed their esophagitis. Effective prevention of complications, such as esophageal adenocarcinoma, remains challenging for all modalities. Patients who have not normalized their GERD-related quality of life with once or twice daily PPI therapy should undergo functional esophageal evaluation with pH testing and esophageal motility study and they should be evaluated by both an endoscopist and a surgeon. The decision on how to proceed should be made on the basis of the criteria for endotherapy and surgery, availability of local endoscopic and surgical expertise and patients’ preference. Such multimodality therapy model is in many ways similar to the long-term management of coronary artery disease where pharmacotherapy, angioplasty, and bypass surgery are frequently used in tandem or in combination. Multimodality therapy aiming at normalization of GERD-related quality of life is an option today, and should be available to all patients in need of therapy. The target population for GERD endotherapy currently consists of PPI-dependent GERD patients, who have a small (<2-cm-long) or no sliding hiatal hernia, and without severe esophagitis or Barrett esophagus. Thus far, only Stretta and the NDO plicator have been studied in sham-controlled trials. Registries of complications suggest that these techniques are relatively safe, but serious morbidity, including rare mortality have been reported (for a continuous update on complications related to endoscopic therapies see: http://www.fda.gov/cdrh/maude.html). All can be performed on an outpatient basis, under intravenous sedation and local pharyngeal anesthesia. Future comparative studies with predetermined clinically significant end points, validated outcome measures, prolonged follow-up, and complete complication registries will eventually determine the precise role of endoscopic procedures for the patients with GERD.
3: Surg Technol Int. 2005;14:139-46Role of endoluminal techniques in treatment of gastro-esophageal reflux disease.Bochkarev V, Ahmed SI, Ringley C, Oleynikov D.
Minimally Invasive Surgical Program, UNMC, Omaha, NE, USA.
This chapter addresses emergent endoluminal technologies available currently for treatment of gastroesophageal reflux disease (GERD). To date, the mainstay of GERD therapy has been achieved with either open or laparoscopic fundoplication, or life-long medical treatment. Endoluminal treatment modalities attempt to augment the gastroesophageal junction (GEJ) function by various techniques. We searched the PubMed database from 1980 to 2005 for studies on endoscopic GERD techniques. Product investigators were contacted for data presented mainly in Abstract form. Endoluminal management of GERD includes using radiofrequency energy, injection of biocompatible polymers, and endoluminal sutures to alter the GEJ and reduce reflux. With currently earned and further growing experience, endoscopic treatment of GERD has future promise; however, more experience and perhaps further refinement in techniques and technology must occur before widespread clinical application can be encouraged.
4: World J Surg. 2008 Aug;32(8):1676-88Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study.
Cadière GB, Buset M, Muls V, Rajan A, Rösch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M,Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Devière J.
BACKGROUND: A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. METHODS: Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm. RESULTS: The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. CONCLUSION: The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.
5: Surg Endosc. 2008 Jun;22(6):1533-46. Epub 2008 Apr 10Advanced endoscopic technologies.Reavis KM, Melvin WS.
The use of endoscopy for diagnosing and treating ailments of the alimentary tract has evolved steadily over the past few decades, with tremendous growth and innovation in the past few years. Initially, endoscopy relied on rigid telescopes, direct visualization, and dangerously exothermic sources of illumination. The introduction of fiber optics, charge-coupled-device cameras, and increasingly efficient light sources has enabled researchers to investigate areas of the human gastrointestinal tract through flexible endoscopy not previously thought to be reachable without formal surgical exploration. The more recent advances in scope platforms, devices, and techniques have allowed researchers to push the envelope of endoscopic diagnostics and therapeutics to greater heights. Specific new platforms include ColonoSight and mother-daughter endoscopes such as the ShapeLock TransPort and the SpyGlass direct visualization system. Specific devices include the EndoCinch suturing system, the full-thickness Plicator procedure, Esophyx, the Stretta system, and the HALO(360) system. Specific new techniques include small-caliber endoscopy, endoscopic mucosal and submucosal resection, and natural orifice translumenal endoscopic surgery (NOTES). This article describes the most relevant recent advances in endoscopic innovation with regard to platform design, devices, and techniques anticipated to serve as the foundation for further research and design for developing generations of endoscopic technologies to come.
6: Surg Endosc. 2008 Feb;22(2):333-42. Epub 2007 Dec 11Endoluminal fundoplication by a transoral device for the treatment of GERD: A feasibility study.Cadière GB, Rajan A, Germay O, Himpens J.
BACKGROUND: A new endoluminal fundoplication (ELF) technique performed transorally using the EsophyXtrade mark device was evaluated for the treatment of gastroesophageal reflux disease (GERD) in a prospective, feasibility clinical trial. METHODS: Nineteen patients were enrolled into the study. Inclusion criteria were chronic and symptomatic GERD, proton pump inhibitor (PPI) dependence, and the absence of esophageal motility disorder. Two patients were excluded due to esophageal stricture and a 6 cm hiatal hernia. The median duration of GERD symptoms and PPI use in the remaining 17 patients was 10 and 6 years, respectively. The ELF procedure was designed to partially reconstruct the antireflux barrier through the creation of a valve at the gastroesophageal junction. RESULTS: The ELF-created valves had a median length of 4 cm (range 3-5 cm) and circumference of 210 degrees (180-270 degrees ). Adherence of the valves to the endoscope was tight (n = 14) or moderate (n = 3). Hiatal hernias present in 13 patients (76%) were all reduced. Adverse events were limited to mild or moderate pharyngeal irritation and epigastric pain, which resolved spontaneously. After 12 months, the ELF valves (n = 16) had a median length of 3 cm (1-4 cm) and a circumference of 200 degrees (150-210 degrees ). Eighty-one percent of valves retained their tightness. The hiatal hernias present at the baseline remained reduced in 62% of patients. The median GERD-HRQL scores improved by 67% (17-6), and nine patients (53%) improved their scores by >or=50%. Eighty-two percent of patients were satisfied with the outcome of the procedure, 82% remained completely off PPIs, and 63% had normal pH. CONCLUSION: The study demonstrated technical feasibility and safety of the ELF procedure using the EsophyX device. The study also demonstrated maintenance of the anatomical integrity of the ELF valves for 12 months and provided preliminary data on ELF efficacy in reducing the symptoms and medication use associated with GERD.
7: Minim Invasive Ther Allied Technol. 2006;15(6):348-55 Endoluminal fundoplication (ELF)–evolution of EsophyX, a new surgical device for transoral surgery.Cadière GB, Rajan A, Rqibate M, Germay O, Dapri G, Himpens J, Gawlicka AK.
A novel endoluminal fundoplication (ELF) technique using a trans-oral and fastener-deploying device (EsophyX, EndoGastric Solutions) was developed and evaluated for feasibility, safety and the treatment of gastroesophageal reflux disease (GERD) in a series of bench, animal, human (phase 1, phase 2, commercial registry) studies. The studies verified biological compatibility, durability and non-toxicity of the polypropylene fasteners as well as the feasibility of the ELF technique. The results of the preclinical testing indicated that the EsophyX device was shown to be safe, and capable of deploying fasteners directly into tissue and forming an interrupted suture line at the base of the gastro-esophageal valve (GEV). Moreover, the studies demonstrated that the ELF technique performed using the EsophyX device resulted in the creation of new GEVs of 3-5 cm in length and a circumference of 200 degrees -310 degrees , which maintained their anatomical aspects at six months. The ELF-created GEVs appeared similar to those created by laparoscopic anti-reflux surgery (LARS). The ELF procedure also resulted in reduction of all small hiatal hernias (2 cm in size) and restoration of the angle of His. The ELF procedure provides an anatomical approach similar to that of LARS for the treatment of GERD.