Greta Saino

Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial.

Objectives:One- and 2-year evaluation of a feasibility trial (clinicaltrials.gov registration numbers NCT01057992, NCT01058070, and 01058564) to assess the safety and efficacy of a laparoscopically implanted sphincter augmentation device for the treatment of gastroesophageal reflux disease (GERD). Methods:A sphincter augmentation device (LINX Reflux Management System; Torax Medical, Shoreview, MN), designed to prevent reflux due to abnormal opening of the lower esophageal sphincter (LES), was laparoscopically implanted at the gastroesophageal junction in 44 patients. At baseline, all patients had abnormal esophageal acid exposure on 24-hour pH monitoring and improved, but persistent, typical GERD symptoms while on acid suppression therapy with proton pump inhibitors (PPIs). The device comprises a miniature string of interlinked titanium beads, with magnetic cores, placed around the gastroesophageal junction. The magnetic bond between adjacent beads augments sphincter competence. The beads temporarily separate to accommodate a swallowed bolus, allow belching or vomiting, and reapproximate to augment the LES in the closed position. Patients were evaluated after surgery by GERD Health-Related Quality of Life symptom score, PPI usage, endoscopy, esophageal manometry, and 24-hour esophageal pH monitoring. Results:The total mean GERD Health-Related Quality of Life symptom scores improved from a mean baseline value of 25.7 to 3.8 and 2.4 at 1- and 2-year follow-up, representing an 85% and 90% reduction, respectively (P < 0.0001). Complete cessation of PPI use was reported by 90% of patients at 1 year and by 86% of patients at 2 years. Early dysphagia occurred in 43% of the patients and self-resolved by 90 days. One device was laparoscopically explanted for persistent dysphagia without disruption of the anatomy or function of the cardia. There were no device migrations, erosions, or induced mucosal injuries. At 1 and 2 years, 77% and 90% of patients had a normal esophageal acid exposure. The mean percentage time pH was less than 4 decreased from a baseline of 11.9% to 3.1% (P < 0.0001) at 1 year and to 2.4% (P < 0.0001) at 2 years. Patient satisfaction was 87% at 1 year and 86% at 2 years. Conclusions:The new laparoscopically implanted sphincter augmentation device eliminates GERD symptoms without creating undue side effects and is effective at 1 and 2 years of follow-up.

Outcome of esophageal adenocarcinoma detected during endoscopic biopsy surveillance for Barrett's esophagus

Background: In an attempt to reduce mortality from esophageal adenocarcinoma, it has been recommended to enroll patients with Barrett’s esophagus in endoscopic surveillance programs in order to detect malignant degeneration at an early and possibly curable stage. The aim of this study was to assess the impact of endoscopic biopsy surveillance on outcome of Barrett’s adenocarcinoma. Methods: Between November 1992 and June 2000, 312 patients with histologically proven esophageal adenocarcinoma were referred to our department. Ninety-seven of these patients had Barrett’s adenocarcinoma. In 12 (12.2%) patients, cancer was discovered during endoscopic surveillance for Barrett’s metaplasia. Results: The prevalence of gastroesophageal reflux disease in the Barrett’s group was 38.8% versus 8% (p < 0.01) in non-Barrett’s patients. In the surveyed group, there were 9 (75%) early stage tumors (Tis-1/N0) versus 9 (10.6%, p < 0.01) in the nonsurveyed patients. Three of 5 surveyed patients operated on for high-grade dysplasia proved to have invasive carcinoma in the esophagectomy specimen. All surveyed patients were alive at a median follow-up of 48 months; the median survival in the nonsurveyed group was 24 ± 3 months (p < 0.01). Conclusion: Endoscopic surveillance of Barrett’s esophagus provides early detection of malignant degeneration and a better long-term survival than in nonsurveyed patients.

One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center

BACKGROUND This study was undertaken to evaluate our clinical experience during a 6-year period with an implantable device that augments the lower esophageal sphincter for gastroesophageal reflux disease (GERD). The device uses magnetic sphincter augmentation (MSA) to strengthen the antireflux barrier. STUDY DESIGN In a single-center, prospective case series, 100 consecutive patients underwent laparoscopic MSA for GERD between March 2007 and February 2012. Clinical outcomes for each patient were tracked post implantation and compared with presurgical data for esophageal pH measurements, symptom scores, and proton pump inhibitor (PPI) use. RESULTS Median implant duration was 3 years (range 378 days to 6 years). Median total acid exposure time was reduced from 8.0% before implant to 3.2% post implant (p < 0.001). The median GERD Health Related Quality of Life score at baseline was 16 on PPIs and 24 off PPIs and improved to a score of 2 (p < 0.001). Freedom from daily dependence on PPIs was achieved in 85% of patients. There have been no long-term complications, such as device migrations or erosions. Three patients had the device laparoscopically removed for persistent GERD, odynophagia, or dysphagia, with subsequent resolution of symptoms. CONCLUSIONS Magnetic sphincter augmentation for GERD in clinical practice provides safe and long-term reduction of esophageal acid exposure, substantial symptom improvement, and elimination of daily PPI use. For candidates of antireflux surgery who have been carefully evaluated before surgery to confirm indication for MSA, MSA has become a standard treatment at our institution because control of reflux symptoms and pH normalization can be achieved with minimal side effects and preservation of gastric anatomy.

Thoracoscopic Management of Chylothorax Complicating Esophagectomy

BACKGROUND Chylothorax is a relatively uncommon complication of esophageal surgery that may lead to severe respiratory, nutritional, and immunologic deficiencies. PATIENTS AND METHODS Between 1992 and 2000, 3 of 316 patients (0.9%) undergoing transthoracic esophagectomy for carcinoma developed postoperative chylothorax. Two of them had previously been treated with neoadjuvant chemoradiation, and one had been submitted to esophagogastric resection through a left thoracotomy. After a 2-week trial of total parenteral nutrition and drainage, two patients underwent thoracic duct ligation via thoracotomy. In the last patient, the operation was completed by thoracoscopy. The azygos vein and the periaortic tissue above the diaphragm were encircled en bloc by a right-angled clamp, and a roticulating endostapler was applied. RESULTS Reoperation was successful in all patients. The postoperative hospital stay was 4 days. CONCLUSION Thoracoscopy is a safe and effective procedure for the treatment of chylothorax complicating esophagectomy. Given the minimal trauma to the patient, early thoracoscopic reoperation can be advocated in patients with high-output chyle loss in order to reduce the hospital stay.

LINX(®) Reflux Management System in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux.

Gastroesophageal reflux disease (GERD) results from incompetency of the lower esophageal sphincter that allows the contents of the stomach to reflux into the esophagus, the airways, and the mouth. The disease affects about 10% of the western population and has a profound negative impact on quality of life. The majority of patients are successfully treated with proton-pump inhibitors, but up to 40% have incomplete relief of symptoms even after dose adjustment. The laparoscopic Nissen fundoplication represents the surgical gold standard, but is largely underused because of the level of technical difficulty and the prevalence of side effects. These factors have contributed to the propensity of patients to continue with medical therapy despite inadequate symptom control and complications of the disease. As a consequence, a significant ‘therapy gap’ in the treatment of GERD remains evident in current clinical practice. The LINX® Reflux Management System (Torax Medical, St. Paul, MN, USA) is designed to provide a permanent solution to GERD by augmenting the sphincter barrier with a standardized, reproducible laparoscopic procedure that does not alter gastric anatomy and is easily reversible. Two single-group trials confirmed that a magnetic device designed to augment the lower esophageal sphincter can be safely and effectively implanted using a standard laparoscopic approach. The device decreased esophageal acid exposure, improved reflux symptoms and quality of life, and allowed cessation of proton-pump inhibitors in the majority of patients.

Rising incidence of esophageal adenocarcinoma in Western countries: is it possible to identify a population at risk?

Symptomatic gastroesophageal reflux disease (GERD) and Barretts mucosa are risk factors for esophageal adenocarcinoma (ADC). The aim of this study was to analyze the anthropometric features and prevalence of GERD in patients with ADC compared with patients with squamous cell carcinoma (SCC) and control subjects. A total of 262 patients with ADC and 302 with SCC were enrolled consecutively. A control group of 262 individuals, sex and age matched to the ADC group, and an additional group of 138 patients with GERD confirmed by 24-h pH monitoring were used for comparison. The prevalence of symptomatic GERD was 32.4% in the subgroup of patients with Barretts ADC (male-female=6.4:1; mean age=62 years) vs. 8% in those with gastric cardia carcinoma (P< 0.01), 3% in the SCC group (P< 0.01), and 10% in the control group (P< 0.01). ADC patients, controls and refluxers had similar body mass index (BMI) that was significantly higher than in the SCC group (P< 0.05). Whether surveillance endoscopy is indicated in men over 50 years with a long-lasting history of GERD and a BMI >25 remains to be determined.

Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement

Abstract Background: As previously reported, the magnetic sphincter augmentation device (MSAD) preserves gastric anatomy and results in less severe side effects than traditional antireflux surgery. The final 5-year results of a pilot study are reported here. Patients and Methods: A prospective, multicenter study evaluated safety and efficacy of the MSAD for 5 years. Prior to MSAD placement, patients had abnormal esophageal acid and symptoms poorly controlled by proton pump inhibitors (PPIs). Patients served as their own control, which allowed comparison between baseline and postoperative measurements to determine individual treatment effect. At 5 years, gastroesophageal reflux disease (GERD)-Health Related Quality of Life (HRQL) questionnaire score, esophageal pH, PPI use, and complications were evaluated. Results: Between February 2007 and October 2008, 44 patients (26 males) had an MSAD implanted by laparoscopy, and 33 patients were followed up at 5 years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the long term, including no device erosions or migrations at any point. Conclusions: Based on long-term reduction in esophageal acid, symptom improvement, and no late complications, this study shows the relative safety and efficacy of magnetic sphincter augmentation for GERD.

Results of Surgical Therapy in Patients with Barrett’s Adenocarcinoma

The incidence of adenocarcinoma arising from Barrett’s esophagus is dramatically increasing in Western countries. The purpose of this study was to report our experience in the surgical management of these patients. Between November 1992 and December 2000, 330 consecutive patients with adenocarcinoma of the esophagogastric junction were observed in our institution. Of these, 105 (31.8%) had Barrett’s carcinoma. In 12 individuals (11.4%) adenocarcinoma was discovered during endoscopic surveillance for Barrett’s esophagus. Twelve patients with doubtful cleavage planes at preoperative investigation were treated with neoadjuvant chemotherapy. Overall, 80 patients (76.2%) underwent esophagectomy without operative mortality. The Ivor Lewis approach was used in 70 patients; of these, 31 underwent extended mediastinal lymph node dissection. Seventy-four patients (92.5%) had R0 resection. The overall 5-year survival rate was 48%. Survival was significantly associated with stage, lymph node status, and completeness of resection. Early diagnosis remains the prerequisite for curative treatment of esophageal carcinoma. An extended mediastinal lymphadenectomy does not increase morbidity, allows precise tumor staging, and may prove effective in preventing local recurrences. Neoadjuvant therapy requires major improvement before it can be unconditionally recommended outside clinical trials.

Current status of minimally invasive endoscopic management for Zenker diverticulum

Surgical resection has been the mainstay of treatment of pharyngoesophageal (Zenker) diverticula over the past century. Developments in minimally invasive surgery and new endoscopic devices have led to a paradigm change. The concept of dividing the septum between the esophagus and the pouch rather than resecting the pouch itself has been revisited during the last three decades and new technologies have been investigated to make the transoral operation safe and effective. The internal pharyngoesophageal myotomy accomplished through the transoral stapling approach has been shown to effectively relieve outflow obstruction and restore physiological bolus transit in patients with medium size diverticula. Transoral techniques, either through a rigid device or by flexible endoscopy, are gaining popularity over the open surgical approach due the low morbidity, the fast recovery time and the fact that the procedure can be safely repeated. We provide an analysis of the the current status of minimally invasive endoscopic management of Zenker diverticulum.

Effect of the Informed Consent Process on Anxiety and Comprehension of Patients Undergoing Esophageal and Gastrointestinal Surgery

ObjectiveThis study seeks to evaluate the level of anxiety, recall, and comprehension of the provided information in patients undergoing esophageal and gastrointestinal surgery.MethodsSixty-one patients without cognitive disorders entered a prospective study designed to assess the effect of a surgical informed consent process. The written informed consent was administered to all patients and was supported by a verbal explanation and a schematic drawing of the operation. The State Trait Anxiety Inventory test was used to assess state anxiety and tract anxiety. The test was repeated after the informed consent process. A disease-specific feedback questionnaire was subsequently administered to assess the actual comprehension of the provided information.ResultsA significant decrease of the state anxiety scores was documented in most patients (p < 0.001). This effect was more evident in the elderly (p = 0.021) and in those who used Internet as a previous source of information (p = 0.032). The mean correct exact answer rate on the disease-specific questionnaire was 76% (IQ range 66.7–85%). No statistically significant relationship was found between the rate of correct answers and the state anxiety scores.ConclusionsAn exhaustive surgical informed consent process was effective in providing comprehension and decreasing anxiety in patients who are candidates to minimally invasive esophageal and gastrointestinal surgical procedures.