EGS Europe- GERD, heartburn, acid reflux

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Clinical Data & Publications

PEER-REVIEWED ARTICLES: EsophyX

1. Endolumenal fundoplication with EsophyX: the Initial North American experience.

Bergman S, Mikami DJ, Hazey JW, Roland JC, Dettorre R, Melvin WS.

EsophyX is a novel endoluminal 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 endoluminal 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 endoluminal 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.

Surgical Innovation 2008 Sep;15:166-170

2. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study.

Cadiere GB, Buset M, Muls V, Rajan A, Rosch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Deviere 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. World Journal of Surgery 2008 Aug;32(8):1676-1688.

World Journal of Surgery 2008 Aug;32(8):1676-1688

3. Nouvelle technique du traitement par voie endoscopique du reflux gastro-oesphagien: la fundoplicature endoluminale.

Cadiere GB, Rajan A, Dapri G, Rqibate M, Germay O, Himpens J.

European Journal of Coelio-surgery 2006; 57:14-19

4.Endoluminal fundoplication by a transoral device for the treatment of GERD: A feasibility study.

Cadiere GB, Rajan A, Germay O, Himpens J.

BACKGROUND: A new endoluminal fundoplication (ELF) technique performed transorally using the EsophyX trademark 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.

Surgical Endoscopy 2008 Feb;22(2):333-342

5. Endoluminal fundoplication (ELF)--evolution of EsophyX, a new surgical device for transoral surgery.

Cadiere 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.

Minimally Invasive Therapy & Allied Technologies 2006;15:348-355

6. Two-year results of a feasibility study on antireflux transoral incisionless fundoplication (TIF) using EsophyX (in press).

Cadiere GB, Van Sante N, Graves JE, Gawlicka AK, Rajan A.

BACKGROUND: A feasibility study (n = 19) evaluated the safety and initial efficacy of TIF for the treatment of gastroesophageal disease (GERD). The results at one year (n = 17) indicated that TIF was safe and had a significant effect on reducing GERD symptoms, proton pump inhibitor (PPI) usage, acid exposure, and small hiatal hernia.

OBJECTIVE: To evaluate the long-term safety and durability of TIF.

METHODS: Fourteen patients (50% female, median age 34 years) completed the two-year follow-up assessment tests. Three patients were excluded from the study after one year because two of them underwent retreatment and one was lost to follow-up.

RESULTS: At two years, no adverse events related to TIF were reported. A ≥ 50% improvement in GERD-HRQL scores compared to those at baseline on PPIs was sustained by 64% of patients. TIF was effective in eliminating heartburn in 93% of patients and daily PPI therapy in 71% of patients. Significantly (P < 0.05) more patients were able to consume reflux-causing foods and maintain lifestyle activities without GERD symptoms compared to baseline on PPIs. Fundoplications were durable and maintained their geometric dimensions. TIF was effective in eliminating hiatal hernia in 60% of patients and esophagitis in 55% of patients. Global assessment of all outcomes in each patient revealed that 79% of patients experienced either a complete cure (29%) or remission (50%) of GERD at two years after TIF.

CONCLUSIONS: The results at two years supported the long-term safety and durability of TIF and its sustained effect on the elimination of heartburn, esophagitis, ≤ 2 cm hiatal hernia, and daily dependence on PPIs.

Surgical Endoscopy (in press 2009)

7. Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease: the anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device.

Jobe BA, O'Rourke RW, McMahon BP, Gravesen F, Lorenzo C, Hunter JG, Bronner M, Kraemer SJ.

OBJECTIVE: To determine the safety, mechanism of action, immediate post-procedural anatomic impact on the esophagogastric junction, and short-term efficacy of the first entirely endoluminal antireflux procedure.

BACKGROUND: A safe and effective endoscopic antireflux procedure remains elusive. Transoral endoluminal surgery has enormous potential for the treatment of gastroesophageal reflux disease (GERD) and other esophagogastric diseases. A canine model was used to study a novel endoscopic device, which allows for creation of an endoluminal fundoplication.

METHODS: The transoral incisionless fundoplication (TIF) was performed in 21 canines in a phase I feasibility and safety study, and in 21 canines in a phase II study that included a detailed objective assessment of the effects of 2 variants of the TIF procedure (TIF 1.0 and TIF 2.0) versus sham on esophageal physiology and esophagogastric junction (EGJ) anatomy.

RESULTS: In phase I, TIF provided a safe and feasible endoluminal therapy for GERD, with histologic data that demonstrated serosal fusion of approximated full-thickness tissue plications and durability of the fundoplication. TIF procedures effectively reduced cardia circumference and improved Hill classification grade. In phase II, the TIF 2.0 procedure achieved normalization of distal esophageal acid exposure and increased lower esophageal sphincter (LES) pressure and length based on objective testing over a 2-week period. TIF 2.0 demonstrated superior results to TIF 1.0, and valve appearance and location exhibited similarity to the Nissen fundoplication by vector volume analysis.

CONCLUSIONS: The TIF procedure is safe and results in a durable and functional fundoplication as well as a platform for further development and modification of the procedure, which can be use to impact outcome. This work provides the foundation for human translation and assessment of long-term outcomes.

Annals of Surgery 2008; 248:69-76

Dean Mikami, Bradley Needleman, Vimal Narula, Janice Durant, W. Scott Melvin.

INTRODUCTION: Weight gain after gastric bypass can occur in up to 10% of patients 5 years following and in about 20% of patients 10 years following surgery. The nadir weight is usually reached within the first 2 years after bypass surgery. However, weight may slowly be regained for numerous reasons. This phenomenon has been studied extensively, but there is often no one reason this occurs. Once psychological and dietary reasons have been investigated, revisional surgery may be the only alternative for treatment. Revisional gastric bypass surgery is associated with a much higher morbidity and mortality when compared with a primary gastric bypass procedure.

PATIENTS AND METHODS: Thirty-nine patients underwent endoluminal gastric pouch reduction with the StomaphyX device after informed consent. The StomaphyX device is a sterile, single-use device for use in endoluminal transoral tissue approximation and ligation in the gastrointestinal (GI) tract.

RESULTS: Average age was 47.8 (29–64) years, and 36/39 (92.3%) patients were female. Average body mass index (BMI) and weight prior to the StomaphyXTM procedure were 39.8 (22.7–63.2) kg/m2 and 108.0 kg (65.90–172.2 kg). The average preprocedure excess body weight was 51.1 kg. Weight loss at 2 weeks (n = 39) was 3.8 kg (7.4% excess body weight loss, EBWL), at 1 month (n = 34) was 5.4 kg (10.6% EBWL), at 2 months (n = 26) was 6.7 kg (13.1% EBWL), at 3 months (n = 15) was 6.7 kg (13.1% EBWL), at 6 months (n = 14) was 8.7 kg (17.0% EBWL), and at 1 year (n = 6) was 10.0 kg (19.5% EBWL). No major complications were observed. The minor complications that were seen included a sore throat lasting less than 48 h in 34/39 patients (87.1%) and epigastric pain that lasted for a few days in 30/39 patients (76.9%). Three patients with chronic diarrhea had their symptoms resolved after the procedure. Eight patients with gastroesophageal reflux disease reported improvement in their symptoms post procedure.

CONCLUSIONS: Endoluminal revision of gastric bypass patients with weight gain using the StomaphyX procedure may offer an alternative to open or laparoscopic revisional bariatric surgery

Surgical Endoscopy July 2009; 0930-2794 (Print) 1432-2218 (Online)

2. Natural orifice surgery (NOS) using StomaphyX for repair of gastric leaks after bariatric revisions.

Overcash WT.

Gastric leaks represent serious complications of bariatric surgery. With the increasing popularity and performance of bariatric procedures, the incidence of leaks and associated complications are expected to increase. Minimally invasive natural orifice surgery represents a novel and promising approach to gastric leak management, especially for morbidly obese patients who are at much higher risk from open or laparoscopic surgical procedures. The present article reports two cases of the safe and successful use of the EndoGastric Solutions StomaphyX device to alter the flow of gastric contents and repair gastric leaks resulting from bariatric revision surgery. Both patients were at a high risk and could not undergo another open or laparoscopic surgery to correct the leaks that were not healing. The StomaphyX procedures lasted approximately 30 min, were performed without any complications, and resulted in the resolution of the gastric leaks in both patients.

Obesity Surgery 2008;18:882-885