Daniel H. Dunn

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.

Experience with minimally invasive esophagectomy

BackgroundMinimally invasive esophagectomy (MIE) is an evolving surgical alternative to traditional open esophagectomy. Despite considerable technical challenges, it was hypothesized that MIE could be performed effectively by surgeons experienced in open esophageal resection and advanced laparoscopic surgery. The authors report their experience with 25 patients who underwent MIE for esophageal disease.MethodsA multidisciplinary esophageal cancer team evaluated all the patients enrolled in this institutional review board–approved retrospective review study. Over an 18-month period, 25 consecutive patients (22 men and 3 women; mean age, 62 years; range, 48–77 years) with resectable esophageal cancer underwent MIE. Six patients were treated with neoadjuvant chemoradiotherapy. The preoperative diagnoses were adenocarcinoma (64%, n = 16), high-grade dysplasia (20%, n = 5), and squamous cell cancer (16%, n = 4). The outcomes evaluated included operative course, hospital and intensive care unit lengths of stay, pathologic stage, morbidity, and mortality.ResultsTwo patients required conversion to open esophagectomy. Operative mortality was 4% (n = 1). The mean operative time was 350 min (range, 300–480), and the average blood loss was 200 ml. The patients remained ventilated for a median of 12 h, and the median intensive care unit utilization was 1 day. The median hospital length of stay was 9 days (range, 6–33 days). Major complications occurred in 32% of the patients. The anastomotic leak rate was 12%. Minor pulmonary complications occurred in 32% and atrial fibrillation in 16% of the patients. An anastomotic stricture developed in 24% of all the patients. One patient showed a positive proximal margin in the final pathology results.ConclusionsMinimally invasive esophagectomy is a technically challenging procedure that can be performed safely at the Virginia Piper Cancer Institute. Optimal results require appropriate patient selection and a multidisciplinary team experienced in the management of esophageal cancer.

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.

Robotic Assisted Operations for Gastroesophageal Reflux

Operative management for gastroesophageal reflux disease (GERD) has evolved into minimally invasive approaches utilizing robotic assisted technologies. Here, we present an overview of robotic assisted operations and outcomes for surgical management of patients with GERD. The specific surgical procedures described here are hiatus hernia repair with and without mesh. Nissen fundoplication a Collis gastroplasty. Additionally, a summary of various pre-operative diagnostic evaluations available for GERD and their relevance in district clinical situations is also provided.

Robotic Operations for Gastroesophageal Reflux Disease

Hiatus hernia repair and fundoplication are currently the most prevalent surgical procedures for management of gastroesophageal reflux disease (GERD) [1, 2]. At present, the operative management for GERD has evolved into a minimally invasive approach. Such minimally invasive laparoscopic approaches have resulted in overall superior outcomes, including fewer postoperative complications and reduced hospital length of stay [3, 4]. Robotic procedures with an abdominal approach for Nissen fundoplication, hiatus hernia repair, Heller myotomy, and trans-hiatal esophagectomy without thoracoscopy or thoracotomy have been performed with encouraging outcomes [5, 6]. The da Vinci® robotic instrument (Intuitive Surgical, Palo Alto, CA) was used for all robotic surgical procedures described in this chapter for management of paraesophageal hiatus hernias, giant hernias, and recurrent hiatus hernias, as well as the more standard anatomy seen in most patients with GERD.

Incarcerated Hiatal Hernia After Robot-Assisted Esophagectomy: Transhiatal Versus Thoracoscopic Approach

To the Editor, We are grateful to Dr. Boone and colleagues for their insightful comments regarding our report on the incidence of incarcerated hiatus hernia after robotic-assisted transhiatal esophagectomy [1]. We agree with Dr. Boone and colleagues that a complication of an incarcerated hiatal hernia should not be induced by a transthoracic approach, as the integrity of the hiatus is maintained by this surgical technique. We wish to mention that our purpose in performing total esophagectomy via robotic transhiatal approach is to eliminate thoracoscopy or thoracotomy either by minimally invasive techniques, such as that utilized by Dr. Boone and coworkers, or as defined and reported by Luketich et al. [2]. Similar to the robotic thoracoscopic and minimally invasive thoracoscopic–laparoscopic approaches, the robotic-assisted transhiatal approach has minimal blood loss, NCCN guideline-recommended lymph node retrieval, acceptable operating times, and low mortality rates. A robotic-assisted transhiatal approach minimizes patient pain and discomfort compared with a thoracic approach, as well as reduces the risks of pulmonary complications that necessarily arise from entering the chest cavity. Relatively few reports of a transhiatal robotic approach for esophagectomy exist in the published literature [3–5]. Since our group is one of the few adopting this approach, the primary intent of the report was to share lessons learned from our initial experience with other surgeons who might wish to pursue this technique. We reiterate that in individuals with an already widened hiatus, a robotic transhiatal procedure poses a risk of stretching the hiatus to a point where a paragastric hiatus hernia may result. As mentioned in our publication, the technique that we suggest is a lateral repair approach by use of an onlay biologic mesh over the lateral part of the hiatus to decrease the size of the hiatus, thereby not impinging on the stomach and possibly compromising the blood supply to the gastric pull-up. Additionally, suturing the graft to the gastric pull-up prevents herniation of small bowel or colon through the hiatus. In closing, we acknowledge the fact that a thoracoscopic esophagectomy would certainly minimize the chances of an incarcerated hiatal hernia. However, since our implementation of the preventive technique (within selected patients) described in our report, we have not encountered any complications of incarcerated hiatus hernia within our practice.

Pathologic Evaluation of Axillary Dissection Specimens Following Unexpected Identification of Tumor Within Sentinel Lymph Nodes

CONTEXT Axillary lymph node dissection has been the standard of care after identification of a positive sentinel lymph node for breast cancer patients. OBJECTIVE To determine the likelihood of non-sentinel lymph node involvement for patients with negative sentinel node by frozen section, who are subsequently found to have tumor cells in the sentinel node by permanent section levels and/or cytokeratin immunohistochemistry. DESIGN One hundred three patients with invasive breast cancer exhibiting negative frozen section evaluation of their sentinel node, but later found to have isolated tumor cells (n  =  46), micrometastasis (n  =  46), or metastases (n  =  11) in their sentinel node by permanent sections or immunohistochemistry, were enrolled in this prospective cohort study and underwent completion axillary dissection. RESULTS Six of 46 patients (13%) with isolated tumor cells in their sentinel node, 15 of 46 patients (33%) with micrometastasis in their sentinel node, and 2 of 11 patients (18%) with metastasis in their sentinel node had additional findings in the nonsentinel nodes. These findings resulted in a pathologic stage change in 2 patients. Predictors of positive nonsentinel nodes were 2 or more positive sentinel nodes (P  =  .002), sentinel nodes with micrometastasis versus isolated tumor cells (P  =  .03), and those with angiolymphatic invasion (P  =  .04). CONCLUSIONS Our findings lend support to axillary node dissection for patients with micrometastasis or metastasis in their sentinel nodes. However, studies with clinical follow-up are needed to determine whether axillary node dissection is necessary for patients with isolated tumor cells in sentinel nodes.